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FDA 510(k)

BioPlex 2200 Lyme Total

K-Number: K183446 · 2019-03-12

ApplicantBio-Rad Laboratories
Decision Date2019-03-12
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BioPlex 2200 Lyme Total is a medical device manufactured by Bio-Rad Laboratories. It received FDA 510(k) clearance on 2019-03-12 under approval number K183446. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioPlex 2200 Lyme Total?

BioPlex 2200 Lyme Total is a medical device that received FDA 510(k) clearance on 2019-03-12. It is manufactured by Bio-Rad Laboratories. The 510(k) number is K183446.

When was BioPlex 2200 Lyme Total approved by the FDA?

BioPlex 2200 Lyme Total received FDA 510(k) clearance on 2019-03-12, under approval number K183446.

What company makes BioPlex 2200 Lyme Total?

BioPlex 2200 Lyme Total is manufactured by Bio-Rad Laboratories.

What is the FDA product code for BioPlex 2200 Lyme Total?

The FDA product code for BioPlex 2200 Lyme Total is LSR.

Other Devices by Bio-Rad Laboratories

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Related Devices (Code: LSR)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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